04-14-2024  8:05 am   •   PDX and SEA Weather
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NORTHWEST NEWS

Four Ballot Measures for Portland Voters to Consider

Proposals from the city, PPS, Metro and Urban Flood Safety & Water Quality District.

Washington Gun Store Sold Hundreds of High-Capacity Ammunition Magazines in 90 Minutes Without Ban

KGW-TV reports Wally Wentz, owner of Gator’s Custom Guns in Kelso, described Monday as “magazine day” at his store. Wentz is behind the court challenge to Washington’s high-capacity magazine ban, with the help of the Silent Majority Foundation in eastern Washington.

Five Running to Represent Northeast Portland at County Level Include Former Mayor, Social Worker, Hotelier (Part 2)

Five candidates are vying for the spot previously held by Susheela Jayapal, who resigned from office in November to focus on running for Oregon's 3rd Congressional District. Jesse Beason is currently serving as interim commissioner in Jayapal’s place. (Part 2)

Winning Powerball Ticket Worth $1.3 Billion Sold in Portland

A Powerball player in Portland has won a jackpot worth more than jumi.3 billion. The prize is the eighth largest in U.S. lottery history. The Oregon Lottery says the winning ticket was sold in Portland, Oregon. The winning numbers were: 22, 27, 44, 52, 69 and the red Powerball 9

NEWS BRIEFS

Americans Willing to Pay More to Eliminate the Racial Wealth Gap, Creating a New Opportunity for Black Business Owners

National research released today provides encouraging news that most Americans are willing to pay a premium price for products and...

Vibrant Communities Commissioner Dan Ryan Directs Development Funding to Complete Next Phase of Gateway Green Project

Portland Parks & Recreation (PP&R) is beginning a new phase of accessibility and park improvements to Gateway Green, the...

Application Opens for Preschool for All 2024-25 School Year

Multnomah County children who will be 3 or 4 years old on or before September 1, 2024 are eligible to apply now for free preschool...

PCC and LAIKA Partner to Foster Diversity in Animation

LAIKA is contributing ,000 to support student scholarships and a new animation and graphics degree. ...

Mt. Hood Community College Hosts Spring Career Fair Featuring Top Portland Employers

The event will be held April 24 at Mt. Hood Community College. ...

Can homeless people be fined for sleeping outside? A rural Oregon city asks the US Supreme Court

GRANTS PASS, Oregon (AP) — A pickleball game in this leafy Oregon community was suddenly interrupted one rainy weekend morning by the arrival of an ambulance. Paramedics rushed through the park toward a tent, one of dozens illegally erected by the town's hundreds of homeless people, then play...

Authorities say 4 people are dead after a train collided with a pickup in rural Idaho

BOISE, Idaho (AP) — Four people are dead after the vehicle they were traveling in was struck by a train in rural Idaho Saturday, authorities said. Idaho State Police said the pickup was carrying a 38-year-old man, 36-year-old woman and two children, who were all from Nampa. The...

Caleb Williams among 13 confirmed prospects for opening night of the NFL draft

NEW YORK (AP) — Southern California quarterback Caleb Williams, the popular pick to be the No. 1 selection overall, will be among 13 prospects attending the first round of the NFL draft in Detroit on April 25. The NFL announced the 13 prospects confirmed as of Thursday night, and...

Georgia ends game on 12-0 run to beat Missouri 64-59 in first round of SEC tourney

NASHVILLE, Tenn. (AP) — Blue Cain had 19 points, Justin Hill scored 17 off the bench and 11th-seeded Georgia finished the game on a 12-0 run to beat No. 14 seed Missouri 64-59 on Wednesday night in the first round of the Southeastern Conference Tournament. Cain hit 6 of 12 shots,...

OPINION

Gallup Finds Black Generational Divide on Affirmative Action

Each spring, many aspiring students and their families begin receiving college acceptance letters and offers of financial aid packages. This year’s college decisions will add yet another consideration: the effects of a 2023 Supreme Court, 6-3 ruling that...

OP-ED: Embracing Black Men’s Voices: Rebuilding Trust and Unity in the Democratic Party

The decision of many Black men to disengage from the Democratic Party is rooted in a complex interplay of historical disenchantment, unmet promises, and a sense of disillusionment with the political establishment. ...

COMMENTARY: Is a Cultural Shift on the Horizon?

As with all traditions in all cultures, it is up to the elders to pass down the rituals, food, language, and customs that identify a group. So, if your auntie, uncle, mom, and so on didn’t teach you how to play Spades, well, that’s a recipe lost. But...

A Full Court Press to Get the Lead Out

With a “goal of identifying and remediating lead hazards in at least 2,800 Lancaster County homes,” LG Health is setting an example for the private sector. And the Biden-Harris administration’s focus on environmental justice and access to clean and safe...

AFRICAN AMERICANS IN THE NEWS

A Pittsburgh congressional race could test Democrats who have criticized Israel's handling of war

HARRISBURG, Pa. (AP) — An election this month in Pittsburgh and some of its suburbs is emerging as an early test of whether Israel’s war with Hamas poses political threats to progressive Democrats in Congress who have criticized how the conflict has been handled. U.S. Rep. Summer...

AI-generated fashion models could bring more diversity to the industry - or leave it with less

CHICAGO (AP) — London-based model Alexsandrah has a twin, but not in the way you’d expect: Her counterpart is made of pixels instead of flesh and blood. The virtual twin was generated by artificial intelligence and has already appeared as a stand-in for the real-life Alexsandrah...

Faith Ringgold, pioneering Black quilt artist and author, dies at 93

NEW YORK (AP) — Faith Ringgold, an award-winning author and artist who broke down barriers for Black female artists and became famous for her richly colored and detailed quilts combining painting, textiles and storytelling, has died. She was 93. The artist's assistant, Grace...

ENTERTAINMENT

Book Review: Jen Silverman’s gripping second novel explores the long afterlife of political violence

Earlier this year a former member of the far-left Baader-Meinhof gang who spent decades in hiding was arrested by German police in connection with a string of crimes. It was just another example of the long afterlife of the anti-war movement of the late 1960s, which Jen Silverman explores in a...

What to stream this week: Billy Joel sings, Dora explores and 'Food, Inc. 2' chows down

A Billy Joel concert special celebrating his residency at Madison Square Garden and Ethan Hawke and Pedro Pascal playing cowboys and former lovers in Pedro Almodóvar’s “Strange Way of Life” are some of the new television, movies, music and games headed to a device near you. ...

Movie Review: ‘Food, Inc. 2’ revisits food system, sees reason for frustration and (a little) hope

The makers of the influential 2008 documentary “Food, Inc.” never planned to make a sequel. They figured they’d said it all in their harrowing look at a broken, unsustainable food system — a system led, they argued, by a few multinational corporations whose monopoly squeezes out local...

U.S. & WORLD NEWS

How to get rid of NYC rats without brutality? Birth control is one idea

New York lawmakers are proposing rules to humanely drive down the population of rats and other rodents, eyeing...

Venezuelans living abroad want to vote for president this year but can't meet absentee requirements

MEXICO CITY (AP) — Giovanny Tovar left Venezuela five years ago in search of a job after his country came undone...

Scottie Scheffler leads Masters by 1 shot on a wild day of movement

AUGUSTA, Ga. (AP) — Scottie Scheffler was in the lead and seemingly in control of his game Saturday in the...

Vatican complains after French court rules in favor of nun dismissed from religious order

ROME (AP) — The Holy See said Saturday it formally protested to France after a court there ruled that a former...

Ukraine's military chief warns of 'significantly' worsening battlefield situation in the east

KYIV, Ukraine (AP) — Ukraine's military chief on Saturday warned that the battlefield situation in the...

Officer, bystanders hailed for confronting and stopping a man who killed 6 at a Sydney shopping mall

SYDNEY (AP) — A police officer and several bystanders are being hailed for running “towards danger” to...

Linda A. Johnson AP Business Writer

TRENTON, N.J. (AP) -- Federal inspectors say the contract manufacturer for Johnson & Johnson's cancer drug Doxil hasn't been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory.

The latest Food and Drug Administration inspection report details lax quality control, failure to follow standard procedures and even lack of follow-up about a container of urine found in the Ben Venue Laboratories Inc. facility, which makes sterile medicines.

Doxil is one of a record 251 medications reported unavailable or in short supply in the U.S. this year, most of them injected drugs crucial for hospital operations. The crisis, blamed on at least 15 deaths, is disrupting patient care and clinical testing of new drugs being compared to or combined with older drugs in short supply.

Ben Venue is the sole supplier for Doxil, which has been in short supply since early summer and is no longer available for new patients.

First approved in 1995, Doxil is used to treat ovarian cancer, the bone cancer multiple myeloma and an HIV-related cancer called Kaposi's sarcoma. Currently, only 2,000 U.S. patients are getting it, and another 2,240 are on a waiting list, according to New Brunswick, N.J.-based J&J.

Ben Venue, part of German drugmaker Boehringer Ingelheim, said three weeks ago that it was temporarily halting manufacture and distribution of all products made at the Bedford plant. It cited an internal review indicating that routine preventive maintenance and tests to ensure manufacturing equipment is operating properly "did not occur at the specified time interval and is overdue."

Ben Venue spokesman Jason Kurtz said Thursday in an e-mailed response to The AP that the company is "working diligently to assess and implement the appropriate corrective actions to address the observations of the FDA investigators."

"Our highest priority is the delivery of safe and effective products to patients," he wrote. "We are continuing to work closely with the FDA with the goal of bringing the products we make back to patients as quickly as possible."

The inspection report posted this week on the FDA's website, covering visits to the factory from Nov. 7 through Dec. 2, details numerous deficiencies not promptly resolved or reported to plant managers. Some problems labeled as "critical" by the factory's quality unit were downgraded to "major" without justification, and the plant's vice presidents for operations and quality were unaware of them when the FDA inspectors asked about them.

The report notes:

-An investigation was opened on Sept. 19 on a 10-gallon can, found in a storage area, that contained a liquid that testing later indicated was urine. Follow-up was "past-due" at the time of the FDA inspectors' visits. Kurtz wrote Thursday that the container of liquid "consistent with urine" was reported to local police and the investigation remains open.

--Monitoring of air samples in manufacturing areas identified microbial contaminants, but Ben Venue did not identify their sources.

-The company doesn't have data showing its "manufacturing process consistently produces product meeting an acceptable level of sterility assurance."

-As of four weeks ago, there were "approximately 107 required preventive maintenance activities" at least 30 days past their scheduled due date.

-Quality-control staff lacked the training, technical expertise and oversight to perform their duties.

Johnson & Johnson spokeswoman Lisa Vaga said J&J does not know when Ben Venue will again be able to ship Doxil, but it has been working on finding additional suppliers since the summer and has found an alternate. The transition will require "an extended period," she said.

Ben Venue announced on Aug. 18 that it would be transitioning out of contract manufacturing over the next several years. That decision followed a May report by FDA inspectors at the same factory stating that, despite complaints dating back to August 2006, the company still had not identified the cause of metal particles contaminating two products that had been distributed. The names of the products were blacked out in the report.

Johnson & Johnson warned doctors on June 21 that it anticipated a shortage of Doxil, which has no generic alternatives. In August, it started a rationing system to allocate Doxil as supplies became available to patients who had started treatment.

As the drug shortages have mounted, President Obama on Oct. 31 ordered the FDA to take several steps to resolve and prevent shortages. The FDA and several members of Congress have been holding hearings since September to identify reasons for and possible solutions to the shortages.

The causes include manufacturing deficiencies leading to production shutdowns, companies ending production of some drugs with tiny profit margins, consolidation in the generic drug industry and limited supplies of some ingredients.

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The Skanner Foundation's 38th Annual MLK Breakfast